NCT06515054

Brief Summary

Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control. Methods: This is a pilot randomized controlled trial that will involve 50 patients with hypertension (HT) who do not meet the current physical activity guidelines defined by the World Health Organization. Participants will be randomly assigned in a 1:1 ratio using stratified and blocked randomization to either the IRE (wall squat) group or stretching exercise (active control) group. A well-structured, widely accepted, and validated 24-week wall squat program (2 minutes per exercise, 2 minutes of rest between sets, and 3 sessions per week) will be implemented, as it has been commonly used in previous research. All patients will be followed up for 24 weeks. Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise. The primary outcome measure will be rate of recruitment. Secondary outcomes will include BP parameters from 24-hour ambulatory BP monitoring

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

December 16, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

July 15, 2024

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of recruitment

    number of people recruited per month

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Blood pressure parameters

    24-week after recruitment

  • Carotid-femoral pulse wave velocity

    24-week after recruitment

  • flow-mediated velocity (FMD)

    24-week after recruitment

Study Arms (2)

isometric exercise

EXPERIMENTAL

wall squat exercise. Each exercise session will contain 4 sets of 2-minute wall squat isometric holds with 2 minutes of rest between each set (approximately 14 minutes per session in total), and a total of 3 sessions will be arranged every week (with ideally 48 h between exercises)

Behavioral: wall squat

passive stretching

ACTIVE COMPARATOR

A frequency-matched (3x/week) and time-matched (\~14 minutes each session) passive static stretching exercise will be used

Behavioral: passive stretching

Interventions

wall squatBEHAVIORAL

self-learnt wall squat exercise to be conducted for totally 24 weeks

isometric exercise

time-matched passive stretching exercise to be conducted for totally 24 weeks

passive stretching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a suboptimal daytime SBP of \>135-160 mmHg on a 24-h ABPM
  • reported no regular physical activity or less than that recommended for adults by the World Health Organization (e.g. \<150 minutes of moderate-intensity aerobic exercise per week);
  • on stable doses of anti-HT medication(s) for ≥4 weeks if the patient is receiving drug treatments
  • agree for no drug changes during the intervention period (24 weeks);

You may not qualify if:

  • cannot provide informed consent
  • unwillingness to repeat ABPM
  • relative contraindications to ABPM (i.e. diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies)
  • severe osteoarthritis pending knee replacement surgery
  • known secondary HT
  • use of ≥3 anti-HT medications at maximum doses or ≥4 anti-HT medications
  • SBP or DBP are \>160 mmHg or \>100 mmHg, respectively, on ABPM
  • pregnancy/breastfeeding
  • active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of public health and primary care

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypertension

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical associate professor

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 23, 2024

Study Start

July 20, 2024

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

December 16, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Locations